Primary Immune ThrombocytopeniaPhase 2NCT06658834
A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP
A Phase 2 study testing Dexamethasone Combined with romiplostim N01 and Dexamethasone monotherapy in people with Primary Immune Thrombocytopenia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This study is a multicenter interventional research on the first-line treatment of newly diagnosed adult patients with immune thrombocytopenia (ITP) using romiplostim N01 in combination with glucocorticoids. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Immune Thrombocytopenia
- What is being tested?
- Dexamethasone Combined with romiplostim N01 and Dexamethasone monotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the written informed consent form before enrollment;
- Age ranging from 18 to 75 years old;
- Be clinically diagnosed with primary immune thrombocytopenia for less than 3 months before randomization;
- Have not received splenectomy or at least one first-line ITP treatment or emergency treatment in the past;
- Have not received romiplostim treatment;
- ECOG PS score: 0 - 2;
Show all 10Show fewer
- Platelet value < 30×10^9/L;
- The expected survival period at the screening is ≥ 12 weeks;
- For subjects of reproductive age, agree to take reliable contraceptive measures throughout the study period (including male or female condoms, contraceptive foams, contraceptive gels, contraceptive membranes, contraceptive ointments, contraceptive suppositories, abstinence, and intrauterine device placement, etc.); Female subjects who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation or menopause for more than 1 year, and male subjects who have undergone bilateral vasectomy or ligation are excluded;
- Voluntarily join this study, sign the informed consent form, and have good compliance.
Who cannot join
- Suffering from other hematopoietic system diseases except ITP, including but not limited to leukemia, thrombocytopenia caused by tumor treatment, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome, etc.;
- Having undergone splenectomy before the first administration;
- Having received ITP drug treatment (including emergency treatment) before the first administration;
- Having used drugs with c-Mpl (thrombopoietin receptor) stimulating effects within 4 weeks before the first administration;
- Having received hematopoietic growth factor preparations (such as granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11, etc.) within 4 weeks before the first administration;
- Having received antibody drugs (such as rituximab, etc.) within 14 weeks before the first administration;
Show all 17Show fewer
- Having received any Chinese herbal medicine or nutritional supplement (except vitamin supplements and mineral supplements) for the purpose of increasing platelets within 1 week before the first administration;
- Having been diagnosed with arterial thrombosis (such as cerebral thrombosis, transient ischemic attack or myocardial infarction), or having a history or complication of venous thrombosis (such as deep vein thrombosis, pulmonary embolism), or using anticoagulants or antiplatelet drugs at the beginning of screening;
- Having a history of severe cardiovascular diseases (such as grade III/IV congestive heart failure, arrhythmia or angina pectoris that increases the risk of thromboembolic events, unstable angina pectoris, having undergone coronary artery stent implantation, angioplasty or coronary artery bypass grafting);
- Secondary thrombocytopenia caused by autoimmune diseases such as antiphospholipid antibody syndrome, systemic lupus erythematosus, Hashimoto's thyroiditis, Even's syndrome and Sjogren's syndrome;
- Positive results for either human immunodeficiency virus antibody or syphilis antibody screening; positive hepatitis C antibody and HCV-RNA exceeding the upper limit of the study center's laboratory test; positive hepatitis B surface antigen and HBV-DNA exceeding the upper limit of the study center's laboratory test;
- Having participated in other clinical studies within 3 months before the first administration;
- Being pregnant or lactating, or having a pregnancy plan;
- Having fertility and being judged by the researcher as not fully adopting contraceptive measures;
- Having a history of severe drug allergic reactions or being known to be allergic to glucocorticoids or Nplate® (romiplostim) or the components of QL0911;
- Unable to comply for mental reasons;
- Judged by the researcher as not suitable to participate in this trial;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, 300000
Lei Zhang, MD, +8613502118379, zhanglei1@ihcams.ac.cn
About this study
Official title: A Multicenter Interventional Study of Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Patients With ITP
This study is a multicenter interventional research on the first-line treatment of newly diagnosed adult patients with immune thrombocytopenia (ITP) using romiplostim N01 in combination with glucocorticoids. The primary endpoint of this study is to assess the efficacy of romiplostim N01 combined with glucocorticoids in untreated newly diagnosed adult ITP patients after 6 months of administration.
The subjects will be divided into the experimental group and the control group for treatment.
Read more
Experimental group: Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously. Simultaneously, romiplostim N01 is administered at an initial dose of 3µg/kg, by subcutaneous injection, once a week, for a maximum of 6 months.
Control group: Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously.
Read the detailed description
This study is a multicenter interventional research, and it is planned to incorporate 129 newly diagnosed adult ITP patients who have not undergone treatment.
For patients meeting the inclusion criteria, after signing the informed consent and passing the screening, they will be randomly grouped.
The study encompasses a screening period (from the signing of the informed consent form by the subject to before the first administration of the drug), a treatment period (including dexamethasone monotherapy and combined treatment of dexamethasone and romiplostim N01), and a follow-up period.
Screening period: Assess the inclusion and exclusion criteria. Those who fulfill the conditions can enter the treatment period.
Treatment period: Baseline visits are conducted for the screened eligible subjects, and they are randomly assigned to the experimental group and the control group at a ratio of 2:1.
Administration protocol:
Experimental group: Dexamethasone (HD-DXM) 40mg/d × 4d, one cycle. If there is no response on the 10th day, repeat once, administered orally or intravenously. Simultaneously, romiplostim N01 is administered, with an initial dose of 3µg/kg, by subcutaneous injection once a week, for up to 6 months.
Control group: Dexamethasone (HD-DXM) 40mg/d × 4d, one cycle. If there is no response on the 10th day, repeat once, administered orally or intravenously.
*Dosage of romiplostim N01: The initial dose is 3µg/kg and can be initiated within 4 days of dexamethasone treatment.
When the platelet count is < 50 × 10^9/L, the patient will receive an increment in the dose of romiplostim N01 by 2µg/kg weekly, with a maximum dose of 10µg/kg. When 200 × 10^9/L > platelet count ≥ 50 × 10^9/L, the administration dosage remains unchanged. When 400 × 10^9/L > platelet count ≥ 200 × 10^9/L for two consecutive weeks, the dose is reduced by 1µg/kg. When the platelet count is ≥ 400 × 10^9/L, discontinue the drug. When the platelet count < 200 × 10^9/L, resume administration, and the administration dose is 1µg/kg less than before drug cessation.
Follow-up period: Enter the follow-up period after the conclusion of treatment. Follow-up: Collect all adverse events (AEs) considered related to the study drug, follow up until the 14th week after the end of treatment, through clinical follow-up or telephone follow-up, and collect information on AEs, concomitant medications and concomitant treatments of the subjects. The researcher can increase the number of visits as necessary for AE follow-up to monitor the alleviation of AEs.
- Conditions
- Primary Immune Thrombocytopenia
- Being tested
- Dexamethasone Combined with romiplostim N01, Dexamethasone monotherapy
- Keywords
- ITP, Romiplostim, Continuous Remission
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Combined with romiplostim N01Drug
Dexamethasone (HD-DXM) at a dose of 40mg/d for 4 days constitutes one cycle. If there is no response on the 10th day, repeat it once. The administration can be either oral or intravenous. Meanwhile, romiplostim N01 is administered with an initial dose of 3µg/kg by subcutaneous injection once a week for up to 6 months.
Dexamethasone monotherapyDrug
Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously.
| Study group | Role | What they receive |
|---|---|---|
| romiplostim combined with glucocorticoids | Experimental | Dexamethasone (HD-DXM) at a dose of 40mg/d for 4 days constitutes one cycle. If there is no response on the 10th day, repeat it once. The administration can be either oral or intravenous. Meanwhile, romiplostim N01 is administered with an initial dose of 3µg/kg by subcutaneous injection once a week for up to 6 months. Receives: Drug: Dexamethasone Combined with romiplostim N01 |
| glucocorticoids | Active comparator | Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously. Receives: Drug: Dexamethasone monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with continuous remission.
Continuous remission is defined as the maintenance of the therapeutic effect of patients for at least 6 months since achieving remission, without the need for additional ITP-specific treatment.
Measured: 6 months
Secondary outcomes (8)
The total effective rate GR
The total effective rate GR = CR + R (Complete response CR, platelet count ≥ 100×10^9/L, and no bleeding symptoms; Effective R, platelet count is between 30×10^9/L and 100×10^9/L, and at least doubles compared to the baseline value, and no bleeding symptoms).
Measured: 6 months
The proportion of patients with the initial response (reaching the effective standard within one month of the start of treatment)
The total effective rate GR = CR + R (Complete response CR, platelet count ≥ 100×10^9/L, and no bleeding symptoms; Effective R, platelet count is between 30×10^9/L and 100×10^9/L, and at least doubles compared to the baseline value, and no bleeding symptoms within one month).
Measured: one month of the start of treatment
The proportion of patients reaching the effective standard 3 months after the start of treatment.
The total effective rate GR = CR + R (Complete response CR, platelet count ≥ 100×10^9/L, and no bleeding symptoms; Effective R, platelet count is between 30×10^9/L and 100×10^9/L, and at least doubles compared to the baseline value, and no bleeding symptoms within 3 month).
Measured: 3 months after the start of treatment
The proportion of patients reaching the effective standard 6 months after the start
The total effective rate GR = CR + R (Complete response CR, platelet count ≥ 100×10^9/L, and no bleeding symptoms; Effective R, platelet count is between 30×10^9/L and 100×10^9/L, and at least doubles compared to the baseline value, and no bleeding symptoms within 6 month).
Measured: 6 months after the start
The maximum consecutive weeks of platelet response
The consecutive weeks with platelet count > 30×10^9/L in the absence of any rescue treatment. Adverse events (evaluated using Version 5.0 of the "Common Terminology Criteria for Adverse Events (NCI CTC AE)") etc.
Measured: 6 months
The proportion of subjects receiving rescue treatment.
The proportion of subjects receiving rescue treatment.
Measured: 6 months
According to the WHO bleeding score standard, the incidence and severity of bleeding symptoms.
According to the WHO bleeding score standard, the incidence and severity of bleeding symptoms.
Measured: 6 months
Adverse events
evaluated using Version 5.0 of the "Common Terminology Criteria for Adverse Events (NCI CTC AE)".
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Jun 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Kunming Medical University, Weifang People's Hospital, Shenzhen Second People's Hospital, The Affiliated Hospital of Qingdao University, Changzhi Medical College, Affiliated Hospital of Nantong University, The First People's Hospital of Yunnan, The First Affiliated Hospital of Bengbu Medical University, Suining Central Hospital, The Second Affiliated Hospital of Dalian Medical University, North China University of Science and Technology, Guizhou Provincial People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658834
- Sponsor's protocol ID
- IIT2024046
- Status last verified
- Apr 2024
- First submitted
- 19 Sep 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Interventional Study of Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Patients With ITP
- ClinicalTrials.gov ID
- NCT06658834
- Acronym / sponsor ID
- IIT2024046
- Conditions
- Primary Immune Thrombocytopenia
- Keywords
- ITP, Romiplostim, Continuous Remission
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Kunming Medical University, Weifang People's Hospital, Shenzhen Second People's Hospital, The Affiliated Hospital of Qingdao University, Changzhi Medical College, Affiliated Hospital of Nantong University, The First People's Hospital of Yunnan, The First Affiliated Hospital of Bengbu Medical University, Suining Central Hospital, The Second Affiliated Hospital of Dalian Medical University, North China University of Science and Technology, Guizhou Provincial People's Hospital
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter interventional research on the first-line treatment of newly diagnosed adult patients with immune thrombocytopenia (ITP) using romiplostim N01 in combination with glucocorticoids. The primary endpoint of this study is to assess the efficacy of romiplostim N01 combined with glucocorticoids in untreated newly diagnosed adult ITP patients after 6 months of administration.
The subjects will be divided into the experimental group and the control group for treatment.
Experimental group: Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously. Simultaneously, romiplostim N01 is administered at an initial dose of 3µg/kg, by subcutaneous injection, once a week, for a maximum of 6 months.
Control group: Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously.
Detailed description
This study is a multicenter interventional research, and it is planned to incorporate 129 newly diagnosed adult ITP patients who have not undergone treatment.
For patients meeting the inclusion criteria, after signing the informed consent and passing the screening, they will be randomly grouped.
The study encompasses a screening period (from the signing of the informed consent form by the subject to before the first administration of the drug), a treatment period (including dexamethasone monotherapy and combined treatment of dexamethasone and romiplostim N01), and a follow-up period.
Screening period: Assess the inclusion and exclusion criteria. Those who fulfill the conditions can enter the treatment period.
Treatment period: Baseline visits are conducted for the screened eligible subjects, and they are randomly assigned to the experimental group and the control group at a ratio of 2:1.
Administration protocol:
Experimental group: Dexamethasone (HD-DXM) 40mg/d × 4d, one cycle. If there is no response on the 10th day, repeat once, administered orally or intravenously. Simultaneously, romiplostim N01 is administered, with an initial dose of 3µg/kg, by subcutaneous injection once a week, for up to 6 months.
Control group: Dexamethasone (HD-DXM) 40mg/d × 4d, one cycle. If there is no response on the 10th day, repeat once, administered orally or intravenously.
*Dosage of romiplostim N01: The initial dose is 3µg/kg and can be initiated within 4 days of dexamethasone treatment.
When the platelet count is < 50 × 10^9/L, the patient will receive an increment in the dose of romiplostim N01 by 2µg/kg weekly, with a maximum dose of 10µg/kg. When 200 × 10^9/L > platelet count ≥ 50 × 10^9/L, the administration dosage remains unchanged. When 400 × 10^9/L > platelet count ≥ 200 × 10^9/L for two consecutive weeks, the dose is reduced by 1µg/kg. When the platelet count is ≥ 400 × 10^9/L, discontinue the drug. When the platelet count < 200 × 10^9/L, resume administration, and the administration dose is 1µg/kg less than before drug cessation.
Follow-up period: Enter the follow-up period after the conclusion of treatment. Follow-up: Collect all adverse events (AEs) considered related to the study drug, follow up until the 14th week after the end of treatment, through clinical follow-up or telephone follow-up, and collect information on AEs, concomitant medications and concomitant treatments of the subjects. The researcher can increase the number of visits as necessary for AE follow-up to monitor the alleviation of AEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| romiplostim combined with glucocorticoids | Experimental | Drug: Dexamethasone Combined with romiplostim N01Dexamethasone (HD-DXM) at a dose of 40mg/d for 4 days constitutes one cycle. If there is no response on the 10th day, repeat it once. The administration can be either oral or intravenous. Meanwhile, romiplostim N01 is administered with an initial dose of 3µg/kg by subcutaneous injection once a week for up to 6 months. |
| glucocorticoids | Active comparator | Drug: Dexamethasone monotherapyDexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Sign the written informed consent form before enrollment;
- Age ranging from 18 to 75 years old;
- Be clinically diagnosed with primary immune thrombocytopenia for less than 3 months before randomization;
- Have not received splenectomy or at least one first-line ITP treatment or emergency treatment in the past;
- Have not received romiplostim treatment;
Key exclusion criteria (17 listed)
- Suffering from other hematopoietic system diseases except ITP, including but not limited to leukemia, thrombocytopenia caused by tumor treatment, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome, etc.;
- Having undergone splenectomy before the first administration;
- Having received ITP drug treatment (including emergency treatment) before the first administration;
- Having used drugs with c-Mpl (thrombopoietin receptor) stimulating effects within 4 weeks before the first administration;
- Having received hematopoietic growth factor preparations (such as granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11, etc.) within 4 weeks before the first administration;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone Combined with romiplostim N01Dexamethasone (HD-DXM) at a dose of 40mg/d for 4 days constitutes one cycle. If there is no response on the 10th day, repeat it once. The administration can be either oral or intravenous. Meanwhile, romiplostim N01 is administered with an initial dose of 3µg/kg by subcutaneous injection once a week for up to 6 months. | Drug | romiplostim combined with glucocorticoids |
| Dexamethasone monotherapyDexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously. | Drug | glucocorticoids |
Primary outcome
The proportion of patients with continuous remission.
Time frame: 6 months
Continuous remission is defined as the maintenance of the therapeutic effect of patients for at least 6 months since achieving remission, without the need for additional ITP-specific treatment.
8 secondary outcomes
The total effective rate GR
Time frame: 6 months
The proportion of patients with the initial response (reaching the effective standard within one month of the start of treatment)
Time frame: one month of the start of treatment
The proportion of patients reaching the effective standard 3 months after the start of treatment.
Time frame: 3 months after the start of treatment
The proportion of patients reaching the effective standard 6 months after the start
Time frame: 6 months after the start
The maximum consecutive weeks of platelet response
Time frame: 6 months
The proportion of subjects receiving rescue treatment.
Time frame: 6 months
According to the WHO bleeding score standard, the incidence and severity of bleeding symptoms.
Time frame: 6 months
Adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
Related trials for Primary Immune Thrombocytopenia
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone Combined with romiplostim N01 and Dexamethasone monotherapy in people with Primary Immune Thrombocytopenia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Zhang, MD (+8613502118379, zhanglei1@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with continuous remission. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.